Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma

NCT ID: NCT02868255

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-03

Study Completion Date

2018-11-30

Brief Summary

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project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.

Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ascites

30 inflammatory ascites of HCC patients (Collection of human samples ) Ascites will be selected only from HCC patients with an elevated protein level (ie inflammatory ascites) Puncture of ascites will be collected by paracentesis on HCC or ovarian cancer patients during their routine care These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).

Collection of human samples

Intervention Type PROCEDURE

Several types of samples will be used to test the effect of the drug candidate

Resections

30 HCC resections (Collection of human samples ) Fragment of resected HCC will be obtained after surgery and histological analysis will be performed by the anatomo-pathology service These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).

Collection of human samples

Intervention Type PROCEDURE

Several types of samples will be used to test the effect of the drug candidate

blood samples

blood samples (Collection of human samples )will be collected prospectively for complementary functional analysis of peripheral These biological samples are affiliated with the biocollection "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).

Collection of human samples

Intervention Type PROCEDURE

Several types of samples will be used to test the effect of the drug candidate

Interventions

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Collection of human samples

Several types of samples will be used to test the effect of the drug candidate

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult
* HCC patients (all BCLC stages accepted)
* patient consent for the use of their biological samples

Exclusion Criteria

* patient with other cancers
* hepatitis C or B positive
* HCC treatment by chemo-embolization under 3 months
* under Sorafenib treatment within the month prior to collection
* underage or under guardianship patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle ARCHAMBEAUD, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Other Identifiers

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RC16_0156

Identifier Type: -

Identifier Source: org_study_id

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